Pelvic Floor Displacement in Women With SUI and Healthy Women: An Ultrasound Study (Stress Urinary Incontinence)

• Conditions: Healthy; Stress Urinary Incontinence

• Registration Number: NCT02930720
• Lead Sponsor: Assuta Hospital Systems

Brief Summary

Pelvic floor main role is to maintain continence. pelvic floor malfunction could lead to urinary incontinence (UI). The known prevalence of UI among women is 25%-72%, in about 25%-50% it is Stress Urinary Incontinence (SUI), SUI prevalence changes with age and obstetric history. SUI is the complaint of involuntary leakage on activities which involves inter abdominal pressure rase, such as effort or exertion, or sneezing or coughing. pelvic floor movement is coordinated with the diaphragm, it moves caudally while inhaling and cranially while exhaling. it was shown that cranial sagittal displacement of the pelvic floor is correlated to pelvic floor normal and efficient function. in order to maintain continence while internal abdominal pressure rises the pelvic floor as to work in a precise trajectory, timing and force. observing the Urinary bladder by trans abdominal ultra sound (TAUS) was found as a valid and reliable way to estimate pelvic floor sagittal displacement and function.

Detailed Description

50 women between the age 25-50 with a history of one vaginal delivery will be recruited for the study. 25 women who complain about stress urinary incontinence (research group) and 25 healthy women (control group). all research participants will sign first a participant consent form. all participants will be interviewed about their own delivery, measured for weight and height and follow a trans abdominal ultra sound (TAUS) examination. the research group participants will be asked to fill a quality of life questionaire concerning their SUI complaint.

at the TAUS examination the participant will be asked to perform:

1. 3 times quiet breathing.

2. 3 times forced exhalation.

3. 3 times cough. while doing so an ultra sound image of the urinary bladder will be saved for displacement measurements.

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-10-10
• Study First Submitted QC: 2016-10-11
• Study First Posted: 2016-10-12
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-12
• Last Update Posted: 2018-01-16
• Primary Completion: 2018-08
• Study Completion: 2018-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

• women after one vaginal delivery on term.
• women aged 25-50
• members of 'macabi medical services'

Exclusion Criteria

• pregnancy
• nulliparous women
• women who had C section delivery
• known neurologic disease
• previous history of pelvic or back surgery
• previous history of pelvic fracture
• known pulmonary disease
• active urinary tract infection

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
pelvic floor displacement	20-30 minutes	in mm

Secondary Outcome Measures

Name	Time	Method
Incontinence Quality of Life (I-QOL)	5 minutes	score of questionaire

Trial Locations

Locations (1)

Macabi hadar yossef; 🇮🇱 Tel Aviv, Israel